The medical community and patient population share concerns about Pradaxa bleeding problems, with Boehringer Ingelheim already facing major legal repercussions for allegedly failing to warn consumers about adverse side effects associated with the medication.

In 2014, Boehringer Ingelheim agreed to a large settlement to resolve numerous product liability claims brought by patients alleging they suffered serious Pradaxa bleeding problems.

Pradaxa is often prescribed to patients who suffer from atrial fibrillation and who are at a high risk for stroke. Like other anticoagulants, Pradaxa works by inhibiting the body’s clotting mechanism to improve overall circulation.

Pradaxa is the first in a line of new generation anticoagulants which were released to compete against its predecessor drug warfarin. Before the release of Pradaxa in 2010, warfarin was the primary treatment choice for patients who were at risk for blood clots. Since its release, two more anticoagulants, Xarelto and Eliquis, were released and have been prescribed to millions of patients.

Unfortunately, the drug has been allegedly causing numerous patients to experience potentially fatal Pradaxa bleeding problems.

Overview of Pradaxa Bleeding Problems

In October 2011, a letter questioning the approval of Pradaxa was published in the medical journal Therapeutics. The letter questioned the reliability of the RE-LY clinical trials, which focused on two patient groups who were prescribed warfarin and Pradaxa.

The letter stated there may have been errors or biases in the study that could have impacted the results and produced an incomplete safety profile. Several months later, the FDA issued a drug safety communication regarding potential Pradaxa bleeding problems. The agency issued the warning after identifying problems with postmarketing reports while trying to determine if Pradaxa was unreasonably dangerous compared to other anticoagulants.

According to a report by the Institute for Safe Medication Practices, over 307 injury reports involving Pradaxa bleeding problems were submitted to the FDA during its first three months on the market.

This surpassed 98.7% of other drugs monitored by the organization, and the medication had a 50% higher likelihood of bleeding problem side effects than Warfarin. Additionally, research suggests patients should be wary of Pradaxa bleeding problems with statistics indicating:

• 16.6% of patients may experience some form of Pradaxa internal bleeding
• 3.3% of patients may experience serious Pradaxa internal bleeding
• 1.5% of patients may experience life-threatening Pradaxa internal bleeding
• 0.3% of patients may experience Pradaxa brain bleeding

It is important to note that elderly patients with kidney problems face the greatest risk of Pradaxa bleeding problems because the drug is processed through the kidneys. Problems arise if the kidneys are unable to properly filter the drug.

Pradaxa patients are encouraged to be vigilant for symptoms of internal bleeding and to report to their doctor or emergency room immediately if any symptoms occur. These symptoms include:

• Unusual Bruising or Bleeding
• Pink or Brown Urine
• Red or Black Stool
• Coughing up Blood
• Headaches and Fatigue
• Bleeding from Gums
• Frequent Nose Bleeds
• Weakness and Swelling in Arms and Legs

Although the makers of Pradaxa recently released a reversal agent to counteract uncontrollable internal bleeding, potentially fatal internal bleeding still remains a risk.